Federal Register / Vol. 72, No. 75 / Thursday, April 19, 2007 / Notices 19711 

Contact: Paul Boben, 410–786–6629 

• Expansion of Coverage of Chiropractic 

Services Demonstration 

Contact: Carol Magee, 410–786–6611 

• Frontier Extended Stay Clinic 

Demonstration Project 

Contact: Sid Mazumdar, 410–786–6673 

• Home Health Agency Prospective Payment 

Demonstration 

Contact: J. Sherwood, 410–786–6651 

• Impact of Payment Reform for Part B 

Covered Outpatient Drugs and Biologicals 

Contact: Usree Bandyopadhyay, 410–786–

6650 

• Informatics for Diabetes Education and 

Telemedicine Demonstration (IDEATel) 

Contact: Diana Ayres: 410–786–7203 

• Inhalation Drug Therapy Demonstration 

Contact: Debbie Vanhoven, 410–786–6625 

• Life Masters 

Contact: Linda Colantino, 410–786–3343 

• Low Vision Rehabilitation Demonstration 

Contact: James Coan, 410–786–9168 

• Massachusetts Senior Care Options 

Contact: William Clark, 410–786–1484 

• Medical Adult Day Care Services 

Demonstration 

Contact: Armen Thoumaian, PhD, 410–

786–6672 

• Medicare + Choice Phase II—PPO 

Demonstration 

Contact: Debbie Vanhoven, 410–786–6625 

• Medicare Advantage CCRC (Erickson) 

Demonstration 

Contact: Henry Bachofer, 410–786–0340 

• Medicare Cancer Registry Record System 

Contact: Gerald Riley, 410–786–6699 

• Medicare Care Management Performance 

Demonstration 

Contact: Jody Blatt, 410–786–6921 

• Medicare Clinical Laboratory Services 

Competitive Bidding Demonstration 

Project 

Contact: Linda Lebovic, 410–786–3402 

• Medicare Coordinated Care Demonstration 

Contact: Cynthia Mason, 410–786–6680 

• Medicare Drug Replacement 

Demonstration 

Contact: Jody Blatt, 410–786–6921 

• Medicare Health Care Quality 

Demonstration Programs 

Contact: Cynthia Mason, 410–786–6680 

• Medicare Home Health Independence 

Demonstration 

Contact: Armen Thoumaian, Ph.D., 410–

786–6672 

• Medicare Hospital Gainsharing 

Demonstration 

Contact: Lisa Waters, 410–786–6615 

• Medicare Preventive Services—Medicare 

Lifestyle Modification Program 

Demonstration 

Contact: Armen Thoumaian, PhD, 410–

786–6672 

• Mercy Medicare Skilled Nursing Facility 

Payment Demonstration 

Contact: J. Sherwood, 410–786–6651 

• Minnesota Senior Health Options 

Contact: Susan Radke, 410–786–4450 

• Municipal Health Services Program 

Demonstration 

Contact: Michael Henesch, 410–786–6685 

• New York Graduate Medical Education 

Demonstration 

Contact: Sid Mazumdar, 410–786–6673 

• Nursing Home Value-Based Purchasing 

Contact: Ronald Lambert, 410–786–6624 

• PACE-for-Profit Demonstration 

Contact: Michael Henesch, 410–786–6685 

• Payment Development, Implementation 

and Monitoring for the BIPA Disease 

Management Demonstration 

Contact: J. Sherwood, 410–786–6651 

• Person-Level Medicaid Data System 

Contact: Dave Baugh, 410–786–7716 

• Physician Group Practice Demonstration 

Contact: John Pilotte, 410–786–6658 

• Premier Hospital Quality Incentive 

Demonstration 

Contact: Katharine Pirotte, 410–786–6774 

• Rural Community Hospital Demonstration 

Contact: Sid Mazumdar, 410–786–6673 

• Rural Hospice Demonstration: Quality 

Assurance Metrics Implementation 

Support 

Contact: Cindy Massuda, 410–786–0652 

• Senior Risk Reduction Demonstration 

Contact: Pauline Lapin, 410–786–6883 

• Social Health Maintenance Organization 

for Long-Term Care Demonstration 

Contact: Thomas Theis, 410–786–6654 

• State-based Home Health Agency TPL 

Payments 

Contact: J. Sherwood, 410–786–6651 

• United Mine Workers of America 

Demonstration 

Contact: Jason Petroski, 410–786–4681 

• Utah Graduate Medical Education 

Contact: Sid Mazumdar, 410–786–6673 

• Wisconsin Partnership Program 

Contact: James Hawthorne, 410–786–6689 

[FR Doc. E7–7403 Filed 4–18–07; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Privacy Act of 1974; Report of a New 

System of Records 

AGENCY: Department of Health and 

Human Services (HHS), Center for 

Medicare & Medicaid Services (CMS). 

ACTION: Notice of a New System of 

Records (SOR). 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

we are proposing to establish a new 

system titled, ‘‘Post-Acute Care Payment 

Reform / Continuity of Assessment 

Report and Evaluation Demonstration 

and Evaluation (PAC–CARE), System 

No. 09–70–0569.’’ The program is 

authorized under Section 5008 of the 

Deficit Reduction Act of 2005, which 

allows for the establishment of a 

demonstration program for purposes of 

understanding costs and outcomes 

across different post-acute care sites. 

The PAC–CARE will collect information 

that will enable CMS to better 

understand the relationships among 

patient needs, post-acute care 

placement, patient outcomes, and postacute care related costs in the Medicare 

program. Anticipated results of the 

PAC–CARE include a standardized 

assessment instrument for post-acute 

care patients and a proposal for siteneutral payment for post-acute care 

services. 

The purpose of this system is to 

collect and maintain demographic, 

health, and health resource use related 

data on the target population of 

Medicare beneficiaries who require 

treatment in a designated acute care or 

post-acute care facility. We will also 

collect certain identifying information 

on Medicare providers who provide 

services to such beneficiaries. 

Information retrieved from this system 

may be disclosed to: (1) Support 

regulatory, reimbursement, and policy 

functions performed within the agency 

or by a contractor, grantee, consultant or 

other legal agent; (2) assist another 

Federal or state agency with information 

to contribute to the accuracy of CMS’s 

proper payment of Medicare benefits, 

enable such agency to administer a 

Federal health benefits program, or to 

enable such agency to fulfill a 

requirement of Federal statute or 

regulation that implements a health 

benefits program funded in whole or in 

part with Federal funds; (3) support an 

individual or organization for a research 

project or in support of an evaluation 

project related to the prevention of 

disease or disability, the restoration or 

maintenance of health, or payment 

related projects; (4) support the 

functions of Quality Improvement 

Organizations; (5) support the functions 

of national accrediting organizations; (6) 

support litigation involving the agency; 

and (7) combat fraud, waste, and abuse 

in certain Federally-funded health 

benefits programs. We have provided 

background information about the new 

system in the SUPPLEMENTARY

INFORMATION section below. Although 

the Privacy Act requires only that CMS 

provide an opportunity for interested 

persons to comment on the proposed 

routine uses, CMS invites comments on 

all portions of this notice. See ‘‘Effective 

Dates’’ section for comment period. 

DATES: Effective Date: CMS filed a new 

SOR report with the Chair of the House 

Committee on Government Reform and 

Oversight, the Chair of the Senate 

Committee on Homeland Security & 

Governmental Affairs, and the 

Administrator, Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB) on 

April 13, 2007. To ensure that all parties 

have adequate time in which to 

comment, the new system will become 

effective 30 days from the publication of 


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19712 Federal Register / Vol. 72, No. 75 / Thursday, April 19, 2007 / Notices 

the notice, or 40 days from the date it 

was submitted to OMB and the 

Congress, whichever is later. We may 

defer implementation of this system or 

one or more of the routine use 

statements listed below if we receive 

comments that persuade us to defer 

implementation. 

ADDRESSES: The public should address 

comments to the CMS Privacy Officer, 

Division of Privacy Compliance, 

Enterprise Architecture and Strategy 

Group, Mail-stop N2–04–27, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. Comments 

received will be available for review at 

this location by appointment during 

regular business hours, Monday through 

Friday from 9 a.m.–3 p.m., eastern time. 

FOR FURTHER INFORMATION CONTACT: 

Shannon Flood, Division of Payment 

Research, Research and Evaluation 

Group, Office of Research Development 

& Information, Mail Stop C3–19–26, 

Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, MD 21244–1849. She can be 

reached by telephone at 410–786–2583, 

or via e-mail at 

Shannon.Flood@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: Medicare 

beneficiaries frequently require postacute care for rehabilitation and 

recovery following a hospital stay. The 

level and length of care required varies 

with the individual patient and the 

condition(s) requiring hospitalization. 

The type of care ranges from outpatient 

therapy to multi-day stays in a variety 

of post-acute care settings. The PAC–

CARE will study Medicare beneficiaries 

as they are discharged from 

participating hospitals and move among 

post-acute care settings. Patient 

functional assessments will be 

performed at regular intervals beginning 

at hospital discharge and continuing as 

patients move among post-acute care 

settings until the episode of care has 

completed. Cost data will be collected 

from the post-acute care settings, 

combined with other cost information 

collected by Medicare Fiscal 

Intermediaries or Carriers, and 

combined with claims and patient 

outcome data to develop a payment 

reform proposal. 

I. Description of the Proposed System of 

Records 

A. Statutory and Regulatory Basis for 

SOR 

The statutory authority for this system 

is given under Section 5008 of the 

Deficit Reduction Act of 2005. 

B. Collection and Maintenance of Data 

in the System 

This system will collect and maintain 

individually identifiable and other data 

collected on Medicare beneficiaries who 

require treatment in a designated acute 

care or post-acute care facility. We will 

also collect certain identifying 

information on Medicare providers who 

provide services to such beneficiaries. 

The collected information will include, 

but is not limited to: Medicare claims 

and eligibility data, name, address, 

telephone number, health insurance 

claims number, race/ethnicity, gender, 

date of birth, provider name, unique 

provider identification number, medical 

record number, as well as clinical, 

demographic, health/well-being, family 

and/or caregiver contact information, 

and background information relating to 

Medicare issues. Data will be collected 

from Medicare administrative and 

claims records, PAC–CARE site 

administrative data systems, patient 

medical charts, physician records, and 

via information submitted by 

beneficiaries and providers. 

II. Agency Policies, Procedures, and 

Restrictions on the Routine Use 

A. The Privacy Act permits us to 

disclose information without an 

individual’s consent if the information 

is to be used for a purpose that is 

compatible with the purpose(s) for 

which the information was collected. 

Any such disclosure of data is known as 

a ‘‘routine use.’’ The Government will 

only release PAC-CARE information that 

can be associated with an individual as 

provided for under ‘‘Section III. 

Proposed Routine Use Disclosures of 

Data in the System.’’ Both identifiable 

and non-identifiable data may be 

disclosed under a routine use. We will 

only collect the minimum personal data 

necessary to achieve the purpose of 

PAC–CARE. 

CMS has the following policies and 

procedures concerning disclosures of 

information that will be maintained in 

the system. Disclosure of information 

from the system will be approved only 

to the extent necessary to accomplish 

the purpose of the disclosure and only 

after CMS: 

1. Determines that the use or 

disclosure is consistent with the reason 

that the data is being collected; e.g., to 

collect and maintain demographic, 

health, and health resource use related 

data on the target population of 

Medicare beneficiaries who require 

treatment in a designated acute care or 

post-acute care facility. We will also 

collect certain identifying information 

on Medicare providers who provide 

services to such beneficiaries. 

2. Determines that: 

a. The purpose for which the 

disclosure is to be made can only be 

accomplished if the record is provided 

in individually identifiable form; 

b. The purpose for which the 

disclosure is to be made is of sufficient 

importance to warrant the effect and/or 

risk on the privacy of the individual that 

additional exposure of the record might 

bring; and 

c. There is a strong probability that 

the proposed use of the data would in 

fact accomplish the stated purpose(s). 

3. Requires the information recipient 

to: 

a. Establish administrative, technical, 

and physical safeguards to prevent 

unauthorized use of disclosure of the 

record; 

b. Remove or destroy, at the earliest 

time, all patient-identifiable 

information; and 

c. Agree to not use or disclose the 

information for any purpose other than 

the stated purpose under which the 

information was disclosed. 

4. Determines that the data are valid 

and reliable. 

III. Proposed Routine Use Disclosures 

of Data in the System 

A. The Privacy Act allows us to 

disclose information without an 

individual’s consent if the information 

is to be used for a purpose that is 

compatible with the purpose(s) for 

which the information was collected. 

Any such compatible use of data is 

known as a ‘‘routine use.’’ The proposed 

routine uses in this system meet the 

compatibility requirement of the Privacy 

Act. We are proposing to establish the 

following routine use disclosures of 

information maintained in the system: 

1. To agency contractors, consultants 

or grantees, who have been engaged by 

the agency to assist in the performance 

of a service related to this collection and 

who need to have access to the records 

in order to perform the activity. 

We contemplate disclosing 

information under this routine use only 

in situations in which CMS may enter 

into a contractual or similar agreement 

with a third party to assist in 

accomplishing CMS function relating to 

purposes for this system. 

CMS occasionally contracts out 

certain of its functions when doing so 

would contribute to effective and 

efficient operations. CMS must be able 

to give a contractor, consultant or 

grantee whatever information is 

necessary for the contractor or 

consultant to fulfill its duties. In these 

situations, safeguards are provided in 


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the contract prohibiting the contractor, 

consultant or grantee from using or 

disclosing the information for any 

purpose other than that described in the 

contract and requires the contractor, 

consultant or grantee to return or 

destroy all information at the 

completion of the contract. 

2. To another Federal or state agency 

to: 

a. Contribute to the accuracy of CMS’s 

proper payment of Medicare benefits; 

b. Enable such agency to administer a 

Federal health benefits program, or, as 

necessary, to enable such agency to 

fulfill a requirement of a Federal statute 

or regulation that implements a health 

benefits program funded in whole or in 

part with Federal funds; and/or 

c. Assist Federal/state Medicaid 

programs within the state. 

Other Federal or state agencies, in 

their administration of a Federal health 

program, may require PAC–CARE 

information in order to support 

evaluations and monitoring of Medicare 

claims information of beneficiaries, 

including proper reimbursement for 

services provided. 

3. To an individual or organization for 

a research project or in support of an 

evaluation project related to the 

prevention of disease or disability, the 

restoration or maintenance of health, or 

payment related projects. 

The PAC–CARE data will provide for 

research or support of evaluation 

projects and a broader, longitudinal, 

national perspective of the status of 

Medicare beneficiaries. CMS anticipates 

that researchers may have legitimate 

requests to use these data in projects 

that could ultimately improve the care 

provided to Medicare beneficiaries and 

the policies that govern their care. 

4. To support Quality Improvement 

Organizations (QIO) in connection with 

review of claims, or in connection with 

studies or other review activities 

conducted pursuant to Part B of Title XI 

of the Act, and in performing affirmative 

outreach activities to individuals for the 

purpose of establishing and maintaining 

their entitlement to Medicare benefits or 

health insurance plans. 

The QIO may use this data to support 

quality improvement activities and 

other QIO responsibilities as detailed in 

Title XI §§ 1151–1164. 

The QIO will work to implement 

quality improvement programs, provide 

consultation to CMS, its contractors, 

and to state agencies. The QIO will 

assist state agencies in related 

monitoring and enforcement efforts, 

assist CMS and intermediaries in 

program integrity assessment, and 

prepare summary information for 

release to CMS. 

5. To assist national accrediting 

organization(s) whose accredited 

facilities are presumed to meet certain 

Medicare requirements for inpatient 

hospital rehabilitation services (e.g., the 

Joint Commission for the Accreditation 

of Healthcare Organizations, the 

American Osteopathic Association, or 

the Commission on Accreditation of 

Rehabilitation Facilities). Information 

will be released to these organizations 

for only those facilities that they 

accredit and that participate in the 

Medicare program and if they meet the 

following requirements: 

a. Provide identifying information for 

post acute care facilities that have an 

accreditation status with the requesting 

deemed organization; 

b. Submission of a finder file 

identifying beneficiaries/patients 

receiving post acute care services; 

c. Safeguard the confidentiality of the 

data and prevent unauthorized access; 

and 

d. Upon completion of a signed data 

exchange agreement or a CMS data use 

agreement. 

At this time, CMS anticipates 

providing accrediting organizations 

with PAC–CARE information to enable 

them to target potential identified 

problems during the organization’s 

accreditation review process of the 

facility. 

6. To the Department of Justice (DOJ), 

court or adjudicatory body when: 

a. The agency or any component 

thereof, or 

b. Any employee of the agency in his 

or her official capacity, or 

c. Any employee of the agency in his 

or her individual capacity where the 

DOJ has agreed to represent the 

employee, or 

d. The United States Government, is 

a party to litigation or has an interest in 

such litigation, and, by careful review, 

CMS determines that the records are 

both relevant and necessary to the 

litigation and that the use of such 

records by the DOJ, court or 

adjudicatory body is compatible with 

the purpose for which the agency 

collected the records. 

Whenever CMS is involved in 

litigation, and occasionally when 

another party is involved in litigation 

and CMS policies or operations could be 

affected by the outcome of the litigation, 

CMS would be able to disclose 

information to the DOJ, court or 

adjudicatory body involved. 

7. To a CMS contractor (including, but 

not necessarily limited to, fiscal 

intermediaries and carriers) that assists 

in the administration of a CMSadministered health benefits program, 

or to a grantee of a CMS-administered 

grant program, when disclosure is 

deemed reasonably necessary by CMS to 

prevent, deter, discover, detect, 

investigate, examine, prosecute, sue 

with respect to, defend against, correct, 

remedy, or otherwise combat fraud, 

waste, and abuse in such program. 

We contemplate disclosing 

information under this routine use only 

in situations in which CMS may enter 

into a contractual, grantee, cooperative 

agreement or consultant relationship 

with a third party to assist in 

accomplishing CMS functions relating 

to the purpose of combating fraud, 

waste, and abuse. CMS occasionally 

contracts out certain of its functions or 

makes grants or cooperative agreements 

when doing so would contribute to 

effective and efficient operations. CMS 

must be able to give a contractor, 

grantee, consultant or other legal agent 

whatever information is necessary for 

the agent to fulfill its duties. In these 

situations, safeguards are provided in 

the contract prohibiting the agent from 

using or disclosing the information for 

any purpose other than that described in 

the contract and requiring the agent to 

return or destroy all information. 

8. To another Federal agency or to an 

instrumentality of any governmental 

jurisdiction within or under the control 

of the United States (including any State 

or local governmental agency), that 

administers, or that has the authority to 

investigate potential fraud, waste, or 

abuse in, a health benefits program 

funded in whole or in part by Federal 

funds, when disclosure is deemed 

reasonably necessary by CMS to 

prevent, deter, discover, detect, 

investigate, examine, prosecute, sue 

with respect to, defend against, correct, 

remedy, or otherwise combat fraud, 

waste, or abuse in such programs. 

Other agencies may require PAC–

CARE information for the purpose of 

combating fraud, waste, and abuse in 

such Federally funded programs. 

B. Additional Provisions Affecting 

Routine Use Disclosures 

To the extent this system contains 

Protected Health Information (PHI) as 

defined by HHS regulation ‘‘Standards 

for Privacy of Individually Identifiable 

Health Information’’ (45 CFR parts 160 

and 164, subparts A and E) 65 FR 82462 

(12–28–00). Disclosures of such PHI that 

are otherwise authorized by these 

routine uses may only be made if, and 

as, permitted or required by the 

‘‘Standards for Privacy of Individually 

Identifiable Health Information.’’ (See 

45 CFR 164.512(a)(1)). 

In addition, our policy will be to 

prohibit release even of data not directly 

identifiable, except pursuant to one of 


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the routine uses or if required by law, 

if we determine there is a possibility 

that an individual can be identified 

through implicit deduction based on 

small cell sizes (instances where the 

patient population is so small that 

individuals could, because of the small 

size, use this information to deduce the 

identity of the beneficiary). 

IV. Safeguards 

CMS has safeguards in place for 

authorized users and monitors such 

users to ensure against unauthorized 

use. Personnel having access to the 

system have been trained in the Privacy 

Act and information security 

requirements. Employees who maintain 

records in this system are instructed not 

to release data until the intended 

recipient agrees to implement 

appropriate management, operational 

and technical safeguards sufficient to 

protect the confidentiality, integrity and 

availability of the information and 

information systems and to prevent 

unauthorized access. 

This system will conform to all 

applicable Federal laws and regulations 

and Federal, HHS, and CMS policies 

and standards as they relate to 

information security and data privacy. 

These laws and regulations may apply 

but are not limited to: the Privacy Act 

of 1974; the Federal Information 

Security Management Act of 2002; the 

Computer Fraud and Abuse Act of 1986; 

the Health Insurance Portability and 

Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare 

Modernization Act of 2003, and the 

corresponding implementing 

regulations. OMB Circular A–130, 

Management of Federal Resources, 

Appendix III, Security of Federal 

Automated Information Resources also 

applies. Federal, HHS, and CMS 

policies and standards include but are 

not limited to: all pertinent National 

Institute of Standards and Technology 

publications; the HHS Information 

Systems Program Handbook and the 

CMS Information Security Handbook. 

V. Effects of the Proposed System of 

Records on Individual Rights 

CMS proposes to establish this system 

in accordance with the principles and 

requirements of the Privacy Act and will 

collect, use, and disseminate 

information only as prescribed therein. 

Data in this system will be subject to the 

authorized releases in accordance with 

the routine uses identified in this 

system of records. 

CMS will take precautionary 

measures to minimize the risks of 

unauthorized access to the records and 

the potential harm to individual privacy 

or other personal or property rights of 

patients whose data are maintained in 

this system. CMS will collect only that 

information necessary to perform the 

system’s functions. In addition, CMS 

will make disclosure from the proposed 

system only with consent of the subject 

individual, or his/her legal 

representative, or in accordance with an 

applicable exception provision of the 

Privacy Act. CMS, therefore, does not 

anticipate an unfavorable effect on 

individual privacy as a result of 

information relating to individuals. 

Dated: April 12, 2007. 

Charlene Frizzera, 

Acting Chief Operating Officer, Centers for 

Medicare & Medicaid Services. 

SYSTEM NO. 09–70–0569 

SYSTEM NAME: 

‘‘Post-Acute Care Payment Reform/ 

Continuity of Assessment Report and 

Evaluation Demonstration and 

Evaluation (PAC–CARE),’’ HHS/CMS/ 

ORDI. 

SECURITY CLASSIFICATION: 

Level Three Privacy Act Sensitive 

Data. 

SYSTEM LOCATION: 

Centers for Medicare & Medicaid 

Services (CMS) Data Center, 7500 

Security Boulevard, North Building, 

First Floor, Baltimore, Maryland 21244–

1850 and at various co-locations of CMS 

agents. 

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM: 

This system will collect and maintain 

individually identifiable and other data 

collected on Medicare beneficiaries who 

require treatment in a designated acute 

care or post-acute care facility. We will 

also collect certain identifying 

information on Medicare providers who 

provide services to such beneficiaries. 

CATEGORIES OF RECORDS IN THE SYSTEM: 

The collected information will 

include, but is not limited to: Medicare 

claims and eligibility data, name, 

address, telephone number, health 

insurance claims number, race/ 

ethnicity, gender, date of birth, provider 

name, unique provider identification 

number, medical record number, as well 

as clinical, demographic, health/wellbeing, family and/or caregiver contact 

information, and background 

information relating to Medicare issues. 

Data will be collected from Medicare 

administrative and claims records, 

PAC–CARE site administrative data 

systems, patient medical charts, 

physician records, and via information 

submitted by beneficiaries and 

providers. 

AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 

The statutory authority for this system 

is given under Section 5008 of the 

Deficit Reduction Act of 2005. 

PURPOSE(S) OF THE SYSTEM: 

The purpose of this system is to 

collect and maintain demographic, 

health, and health resource use related 

data on the target population of 

Medicare beneficiaries who require 

treatment in a designated acute care or 

post-acute care facility. We will also 

collect certain identifying information 

on Medicare providers who provide 

services to such beneficiaries. 

Information retrieved from this system 

may be disclosed to: (1) Support 

regulatory, reimbursement, and policy 

functions performed within the agency 

or by a contractor, grantee, consultant or 

other legal agent; (2) assist another 

Federal or state agency with information 

to contribute to the accuracy of CMS’s 

proper payment of Medicare benefits, 

enable such agency to administer a 

Federal health benefits program, or to 

enable such agency to fulfill a 

requirement of Federal statute or 

regulation that implements a health 

benefits program funded in whole or in 

part with Federal funds; (3) support an 

individual or organization for a research 

project or in support of an evaluation 

project related to the prevention of 

disease or disability, the restoration or 

maintenance of health, or payment 

related projects; (4) support the 

functions of Quality Improvement 

Organizations; (5) support the functions 

of national accrediting organizations; (6) 

support litigation involving the agency; 

and (7) combat fraud, waste, and abuse 

in certain Federally-funded health 

benefits programs. 

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OR USERS AND

THE PURPOSES OF SUCH USES: 

A. The Privacy Act allows us to 

disclose information without an 

individual’s consent if the information 

is to be used for a purpose that is 

compatible with the purpose(s) for 

which the information was collected. 

Any such compatible use of data is 

known as a ‘‘routine use.’’ The proposed 

routine uses in this system meet the 

compatibility requirement of the Privacy 

Act. We are proposing to establish the 

following routine use disclosures of 

information maintained in the system: 

1. To agency contractors, consultants 

or grantees, who have been engaged by 

the agency to assist in the performance 

of a service related to this collection and 


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Federal Register / Vol. 72, No. 75 / Thursday, April 19, 2007 / Notices 19715 

who need to have access to the records 

in order to perform the activity. 

2. To another Federal or state agency 

to: 

a. Contribute to the accuracy of CMS’s 

proper payment of Medicare benefits; 

b. Enable such agency to administer a 

Federal health benefits program, or, as 

necessary, to enable such agency to 

fulfill a requirement of a Federal statute 

or regulation that implements a health 

benefits program funded in whole or in 

part with Federal funds; and/or 

c. Assist Federal/state Medicaid 

programs within the state. 

3. To an individual or organization for 

a research project or in support of an 

evaluation project related to the 

prevention of disease or disability, the 

restoration or maintenance of health, or 

payment related projects. 

4. To support Quality Improvement 

Organizations (QIO) in connection with 

review of claims, or in connection with 

studies or other review activities 

conducted pursuant to Part B of Title XI 

of the Act, and in performing affirmative 

outreach activities to individuals for the 

purpose of establishing and maintaining 

their entitlement to Medicare benefits or 

health insurance plans. 

5. To assist national accrediting 

organization(s) whose accredited 

facilities are presumed to meet certain 

Medicare requirements for inpatient 

hospital rehabilitation services (e.g., the 

Joint Commission for the Accreditation 

of Healthcare Organizations, the 

American Osteopathic Association, or 

the Commission on Accreditation of 

Rehabilitation Facilities). Information 

will be released to these organizations 

for only those facilities that they 

accredit and that participate in the 

Medicare program and if they meet the 

following requirements: 

a. Provide identifying information for 

post acute care facilities that have an 

accreditation status with the requesting 

deemed organization; 

b. Submission of a finder file 

identifying beneficiaries/patients 

receiving post acute care services; 

c. Safeguard the confidentiality of the 

data and prevent unauthorized access; 

and 

d. Upon completion of a signed data 

exchange agreement or a CMS data use 

agreement. 

6. To the Department of Justice (DOJ), 

court or adjudicatory body when: 

a. The agency or any component 

thereof, or 

b. Any employee of the agency in his 

or her official capacity, or 

c. Any employee of the agency in his 

or her individual capacity where the 

DOJ has agreed to represent the 

employee, or 

d. The United States Government, is 

a party to litigation or has an interest in 

such litigation, and, by careful review, 

CMS determines that the records are 

both relevant and necessary to the 

litigation and that the use of such 

records by the DOJ, court or 

adjudicatory body is compatible with 

the purpose for which the agency 

collected the records. 

7. To a CMS contractor (including, but 

not necessarily limited to, fiscal 

intermediaries and carriers) that assists 

in the administration of a CMSadministered health benefits program, 

or to a grantee of a CMS-administered 

grant program, when disclosure is 

deemed reasonably necessary by CMS to 

prevent, deter, discover, detect, 

investigate, examine, prosecute, sue 

with respect to, defend against, correct, 

remedy, or otherwise combat fraud, 

waste, and abuse in such program. 

8. To another Federal agency or to an 

instrumentality of any governmental 

jurisdiction within or under the control 

of the United States (including any State 

or local governmental agency), that 

administers, or that has the authority to 

investigate potential fraud, waste, or 

abuse in, a health benefits program 

funded in whole or in part by Federal 

funds, when disclosure is deemed 

reasonably necessary by CMS to 

prevent, deter, discover, detect, 

investigate, examine, prosecute, sue 

with respect to, defend against, correct, 

remedy, or otherwise combat fraud, 

waste, or abuse in such programs. 

B. Additional Provisions Affecting 

Routine Use Disclosures 

To the extent this system contains 

Protected Health Information (PHI) as 

defined by HHS regulation ‘‘Standards 

for Privacy of Individually Identifiable 

Health Information’’ (45 CFR parts 160 

and 164, subparts A and E) 65 FR 82462 

(12–28–00). Disclosures of such PHI that 

are otherwise authorized by these 

routine uses may only be made if, and 

as, permitted or required by the 

‘‘Standards for Privacy of Individually 

Identifiable Health Information.’’ (See 

45 CFR 164.512(a) (1)). 

In addition, our policy will be to 

prohibit release even of data not directly 

identifiable, except pursuant to one of 

the routine uses or if required by law, 

if we determine there is a possibility 

that an individual can be identified 

through implicit deduction based on 

small cell sizes (instances where the 

patient population is so small that 

individuals could, because of the small 

size, use this information to deduce the 

identity of the beneficiary). 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

STORAGE: 

All records are stored on electronic 

media. 

RETRIEVABILITY: 

The collected data are retrieved by an 

individual identifier; e.g., beneficiary 

name or HICN. 

SAFEGUARDS: 

CMS has safeguards in place for 

authorized users and monitors such 

users to ensure against unauthorized 

use. Personnel having access to the 

system have been trained in the Privacy 

Act and information security 

requirements. Employees who maintain 

records in this system are instructed not 

to release data until the intended 

recipient agrees to implement 

appropriate management, operational 

and technical safeguards sufficient to 

protect the confidentiality, integrity and 

availability of the information and 

information systems and to prevent 

unauthorized access. 

This system will conform to all 

applicable Federal laws and regulations 

and Federal, HHS, and CMS policies 

and standards as they relate to 

information security and data privacy. 

These laws and regulations may apply 

but are not limited to: the Privacy Act 

of 1974; the Federal Information 

Security Management Act of 2002; the 

Computer Fraud and Abuse Act of 1986; 

the Health Insurance Portability and 

Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare 

Modernization Act of 2003, and the 

corresponding implementing 

regulations. OMB Circular A–130, 

Management of Federal Resources, 

Appendix III, Security of Federal 

Automated Information Resources also 

applies. Federal, HHS, and CMS 

policies and standards include but are 

not limited to: all pertinent National 

Institute of Standards and Technology 

publications; the HHS Information 

Systems Program Handbook and the 

CMS Information Security Handbook. 

RETENTION AND DISPOSAL: 

Records will be retained until an 

approved disposition authority is 

obtained from the National Archives 

and Records Administration. All claimsrelated records are encompassed by the 

document preservation order and will 

be retained until notification is received 

from DOJ. 

SYSTEM MANAGER AND ADDRESS: 

Director, Research and Evaluation 

Group, Office of Research Development 


cprice-sewell on PROD1PC66 with NOTICES
19716 Federal Register / Vol. 72, No. 75 / Thursday, April 19, 2007 / Notices 

& Information, Mail Stop C3–19–26, 

Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, MD 21244–1849. 

NOTIFICATION PROCEDURE: 

For purpose of access, the subject 

individual should write to the system 

manager who will require the system 

name, employee identification number, 

tax identification number, national 

provider number, and for verification 

purposes, the subject individual’s name 

(woman’s maiden name, if applicable), 

HICN, and/or SSN (furnishing the SSN 

is voluntary, but it may make searching 

for a record easier and prevent delay). 

RECORD ACCESS PROCEDURE: 

For purpose of access, use the same 

procedures outlined in Notification 

Procedures above. Requestors should 

also reasonably specify the record 

contents being sought. (These 

procedures are in accordance with 

Department regulation 45 CFR 5b.5 

(a)(2)). 

CONTESTING RECORD PROCEDURES: 

The subject individual should contact 

the system manager named above, and 

reasonably identify the record and 

specify the information to be contested. 

State the corrective action sought and 

the reasons for the correction with 

supporting justification. (These 

procedures are in accordance with 

Department regulation 45 CFR 5b.7). 

RECORDS SOURCE CATEGORIES: 

Data will be collected from Medicare 

administrative and claims records 

(Outcome and Assessment Information 

Set, Inpatient Rehabilitation Facilities 

Patient Assessment Instrument, Long 

Term Care Minimum Data Set), postacute care site administrative data 

systems, patient medical charts, 

physician records, and via information 

submitted by beneficiaries and 

providers. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

[FR Doc. E7–7404 Filed 4–18–07; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0077] 

Withdrawal of Approval of New Animal 

Drug Applications; Pyrantel; Tylosin; 

Tylosin and Sulfamethazine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of three new animal drug 

applications (NADAs) for intermediate 

premixes used to manufacture Type C 

medicated feeds. In a final rule 

published elsewhere in this issue of the 

Federal Register, FDA is amending the 

animal drug regulations to remove 

portions reflecting approval of these 

NADAs. 

FOR FURTHER INFORMATION CONTACT: 

Pamela K. Esposito, Center for 

Veterinary Medicine (HFV–212), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855, 240–276–

9067, e-mail: 

pamela.esposito@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Custom 

Feed Services Corp., 2100 N. 13th St., 

Norfolk, NE 68701, has requested that 

FDA withdraw approval of NADA 121–

200 for Tylosin 10 Premix (tylosin), 

NADA 129–159 for TYLAN 40 Sulfa-G 

(tylosin and sulfamethazine), and 

NADA 137–484 for Swine Guard-BN 

(pyrantel). All are intermediate 

premixes used to manufacture Type C 

medicated feeds. This action is 

requested because the products are no 

longer manufactured or marketed. 

Therefore, under authority delegated 

to the Commissioner of Food and Drugs, 

redelegated to the Center for Veterinary 

Medicine, and in accordance with 21 

CFR 514.115 Withdrawal of approval of 

applications, notice is given that 

approval of NADA 121–200, NADA 

129–159, and NADA 137–484, and all 

supplements and amendments thereto, 

are hereby withdrawn, effective April 

30, 2007. 

In a final rule published elsewhere in 

this issue of the Federal Register, FDA 

is amending the animal drug regulations 

to reflect the withdrawal of approval of 

these NADAs. 

Dated: April 9, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–7461 Filed 4–18–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0078] 

Withdrawal of Approval of New Animal 

Drug Applications; Estradiol Benzoate 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has withdrawn 

approval of two new animal drug 

applications (NADAs) for a suspension 

implant of estradiol benzoate 

microspheres used in steers and heifers 

fed in confinement for slaughter for 

increased rate of weight gain and 

improved feed efficiency, and in 

suckling beef calves for increased rate of 

weight gain. In a final rule published 

elsewhere in this issue of the Federal 

Register, FDA is amending the animal 

drug regulations to remove portions 

reflecting approval of these NADAs. 

FOR FURTHER INFORMATION CONTACT: 

Pamela K. Esposito, Center for 

Veterinary Medicine (HFV–212), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855, 240–276–

9067; e-mail: 

pamela.esposito@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: PR 

Pharmaceuticals, Inc., 1716 Heath 

Pkwy., Fort Collins, CO 80524, has 

requested that FDA withdraw approval 

of NADA 141–040 for DURALEASE 

(estradiol benzoate), a suspension 

implant of estradiol benzoate 

microspheres used in steers and heifers 

fed in confinement for slaughter for 

increased rate of weight gain and 

improved feed efficiency and NADA 

141–041 for CELERIN-C (estradiol 

benzoate), a similar product used in 

suckling beef calves for increased rate of 

weight gain. This action is requested 

because the products are no longer 

manufactured or marketed. 

Therefore, under authority delegated 

to the Commissioner of Food and Drugs, 

redelegated to the Center for Veterinary 

Medicine, and in accordance with 21 

CFR 514.115, notice is given that 

approval of NADA 141–040 and NADA 

141–041 and all supplements and 

amendments thereto, were withdrawn 

as of September 29, 2006. 

In a final rule published elsewhere in 

this issue of the Federal Register, FDA 

is amending the animal drug regulations 

to reflect the withdrawal of approval of 

these NADAs. 

Dated: April 9, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. 07–1941 Filed 4–18–07; 8:45 am] 

BILLING CODE 4160–01–S 


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